FDA 510(k)

Cortera脊椎固定系統

K 號：K221403 · 2022-08-19

決定日期2022-08-19

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Cortera Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Surgalign Spine Technologies. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K221403. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cortera Spinal Fixation System?

Cortera Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Surgalign Spine Technologies. The 510(k) number is K221403.

When did Cortera Spinal Fixation System receive FDA 510(k) clearance?

Cortera Spinal Fixation System received FDA 510(k) clearance on 2022-08-19, under 510(k) number K221403.

Who is the listed applicant for Cortera Spinal Fixation System?

The FDA 510(k) record lists Surgalign Spine Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cortera Spinal Fixation System?

The FDA product code for Cortera Spinal Fixation System is NKB.

其他以 Surgalign Spine Technologies 為申請人之記錄

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相關器械（代碼：NKB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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